San Fermo Della Battaglia

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are investigating patients affected by aneurysmal subarachnoid hemorrhage (aSAH), a type of hemorrhagic stroke caused by the rupture of a brain aneurysm, leading to bleeding in the space around the brain. Although early treatment has improved survival, many patients still develop long-term disabling neurological problems. The study focuses on delayed ischemic neurological deficit (DIND), a condition that can lead to delayed cerebral ischemia (DCI) and worsened neurological outcomes. There is no established standard for diagnosing or treating DIND, and the trial aims to describe its incidence, diagnostic imaging findings, and different treatment approaches across centers. The study observes patients with aSAH who require intensive care admission. Early aneurysm repair within 24 to 72 hours is standard, using techniques like endovascular coiling or surgical clipping. The trial collects data on clinical neurological exams and instrumental monitoring such as EEG and ultrasound to identify DIND. Various treatments for DIND are evaluated, including blood pressure management, intra-arterial vasodilator drugs, and mechanical angioplasty. The study also considers innovative methods like stent retriever angioplasty. No specific interventions are assigned by the study; it compares existing diagnostic and therapeutic strategies used in different centers. Participants undergo neurological assessments, brain imaging, and continuous monitoring to detect DIND and evaluate neurological outcomes over time. Researchers collect data on mortality and functional status in the short and long term, as well as treatment intensity and usefulness. The primary measure is the incidence of DIND within 12 months. The total duration of participation depends on patient follow-up. This comprehensive monitoring helps understand how different approaches impact patient recovery and complications after aSAH.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.